Bi-directional fixating transvertebral body screws, zero-profile horizontal intervertebral miniplates, total intervertebral body fusion devices, and posterior motion-calibrating interarticulating joint stapling device for spinal fusion

ABSTRACT

An apparatus and method for joining members together using a self-drilling screw apparatus or stapling apparatus are disclosed. The screw apparatus includes a worm drive screw, a spur gear and superior and inferior screws which turn simultaneously in a bi-directional manner. A rotating mechanism drives the first and second screw members in opposite directions and causes the screw members to embed themselves in the members to be joined. The screw apparatus can be used to join members such as bones, portions of the spinal column, vertebral bodies, wood, building materials, metals, masonry, or plastics. A device employing two screws (two-in-one) can be combined with a capping horizontal mini-plate. A device employing three screws can be combined in enclosures (three-in-one). The stapling apparatus includes grip handles, transmission linkages, a drive rod a fulcrum and a cylinder. The staple has superior and inferior segments with serrated interfaces, a teethed unidirectional locking mechanism and four facet piercing elements. The staples can be also be used to join members such as bones, portions of the spinal column, or vertebral bodies.

The present Application is a Continuation Application of U.S. patentapplication Ser. No. 12/868,451 filed Aug. 25, 2010, which is aDivisional Application of U.S. patent application Ser. No. 11/536,815filed on Sep. 29, 2006, now U.S. Pat. No. 7,846,188 issued Dec. 7, 2010,which is a Continuation-In-Part Application of U.S. patent applicationSer. No. 11/208,644, filed on Aug. 23, 2005, now U.S. Pat. No. 7,704,279issued on Apr. 27, 2010, for which priority is claimed under 35 U.S.C. §120; and this application also claims priority under 35 U.S.C. § 119(e)of U.S. provisional application No. 60/670,231, filed on Apr. 12, 2005;the entire contents of all the above identified patent applications arehereby incorporated by reference.

FIELD OF INVENTION

The present invention relates to a unique universal bidirectional screw(UBS) system , and in particular its application to the spine, alsoreferred to as bi-directional fixating transvertebral (BDFT) screwswhich can be used to supplement other intervertebral spacers and/or bonefusion materials. BDFT screws can be incorporated into anterior and/orposterior cervical, thoracic and lumbosacral, novel, zero-profile,horizontal intervertebral mini-plates, and anterior cervical, thoracicand lumbosacral total interbody fusion devices (IBFD). In thelumbosacral and thoracic spine, BDFT screws can be used independently orsupplemented with the horizontal intervertebral mini-plate or totalIBFD, and are thus considered stand alone intervertebral body fusionconstructs which may obviate the need for supplemental pedicle screwfixation. In the cervical spine these devices obviate the need forsupplemental vertically oriented anterior plating, and can be used asstand alone interbody fusion devices. The present invention also relatesto a stand-alone or supplemental, calibrating interarticular jointstapling device which can incrementally fine-tune posteriorinterarticular joint motion.

DESCRIPTION OF THE RELEVANT ART

Segmental spinal fusions which stabilize two or more adjacent segmentsof the spine are performed for painful degenerative disc disease,recurrent disc herniations, spinal stenosis, spondylolysis andspondylolisthesis. Over the past several decades a wide variety offusion techniques and instrumentation have evolved. One of the earliestposterior fusion techniques entails non-instrumented in-situ on-layposteriolateral fusion utilizing autologous iliac crest bone. Because ofthe high rate of imperfect fusions i.e. pseudoarthroses, transpedicularpedicle screw fixation which utilizes a variety of rods andinterconnectors were developed to achieve less interbody motion andhence higher fusion rates. Pedicle screw fixation was initially combinedwith on-lay posteriolateral fusion. Because of the poor blood supply ofthe transverse processes, issues still remained with pseudoarthroses. Inan attempt to address this problem, pedicle screw fixation has beensupplemented with a variety of interbody fusion devices. This is basedon the concept that axial loading enhances fusion and that the vertebralendplates have a better blood supply. Interbody lumbar fusion devicescan be placed anteriorly via an anterior lumbar interbody fusiontechnique (ALIF) or posteriorly via a posterior lumbar interbody fusiontechnique (PLIF). Material options for interbody fusion devices haveincluded autologous iliac crest/laminar bone, cylindrical threadedtitanium interbody cages, cylindrical threaded cortical bone dowels,vertebral interbody rings or boxes, carbon fiber cages, or femoral ringallograft. To lessen the complication of prolonged nerve root retractionthe technique of circumferential transforaminal lumbar interbody fusiontechnique (TLIF) has been introduced. This employs the transforaminalplacement of an interbody spacer such as one kidney bean shapedallograft, two circular allografts, one or two titanium circular cages,a single titanium or Peek (poly-ether-ketone) boomerang spacer. Thethreaded spacers are usually supplemented with autologous bone and/orbone morphogenic protein (BMP), demineralized bone matrix (DBM) in theform of paste or cement, rh-BMP with collagen sponges, or similarosteoinductive biological agents which are known to enhance fusion.

Currently all lumbosacral fusion techniques, ALIF, PLIF and TLIF, aretypically supplemented by pedicle screw placement. In addition posteriortransfacet screws also have been used to supplement ALIF procedures.Complications of pedicle screw placement include duration of procedure,significant tissue dissection and muscle retraction, misplaced screwswith neural and/or vascular injury, excessive blood loss, need fortransfusions, prolonged recovery, incomplete return to work, excessrigidity leading to adjacent segmental disease requiring further fusionsand re-operations. Further advances of pedicle screw fixation includingminimally invasive and image-guided technology, and the development offlexible rods have imperfectly addressed some but not all of theseissues. Transfacet screws and similar embodiments entail the use ofshort or long screws which provide static facet alignment without motioncalibration.

Complications of all current interbody fusion devices is their lack ofcoverage of the majority of the cross sectional area of the vertebralendplates and their potential for extrusion. The recently describedflexible fusion system which consists of flexible rods attached totranspedicular screws (Dionysis, Zimmer) suffers from a high pull-outrate, higher rate of re-operation than standard fusions, and does notrank high with patient satisfaction. See for example, Clinicalexperience with the Dynesys semirigid fixation system for the lumbarspine: Surgical and patient-oriented outcome in 50 cases after anaverage of 2 years; D, Grob, A. Benini and A. F. Mannion. Spine Volume30, number 3, Fe. 1, 2005.

Single or multiple level anterior cervical spinal fusions typicallyemploy the replacement of the cervical disc or discs with autologous orallograft bone, or an intervertebral spacer filled with autologous orallograft bone, demineralized bone matrix, BMP or rh-BMP etc. Currentlythese anterior cervical fusions are augmented with anterior verticaltitanium plates which cross the intervertebral space or spaces and aresecured to the vertebral bodies above and below the disc space or spaceswith perpendicularly penetrating vertebral body screws. The purpose ofthese plates is to serve as a barrier to prevent extrusion of theintervertebral disc replacement. Recently anterior vertical plating hasalso been employed in anterior lumbar fusion.

Complications of anterior spinal plating include the potential forneurovascular injury with screw misplacement, screw and/or platepull-out, and screw and/or plate breakage. Other complications includepotential esophageal compression/injury in the cervical spine secondaryto high plate profile or pull-out, and to potential devastating vascularinjury in the lumbar spine with plate movement and/or dislodgement intoanterior iliac vasculature. Recent advances in cervical plating havetherefore concentrated on the creation of lower profile plates and evenresorbable plates. These advances, however, have not eliminated thepossibility of plate dislodgement and screw back out/breakage.

OBJECTS OF THE INVENTION

To achieve segmental fusion, applicants propose the use of novelbi-directional fixating transvertebral (BDFT) screws which can bestrategically inserted via anterior or posterior surgical spinalapproaches into the anterior and middle columns of the intervertebraldisc space. The BDFT mechanism employs turning a wormed driving screwwhich then turns a spur gear which in turn simultaneously turns arostrally oriented screw into the cephalad vertebral body, and acaudally directed screw into the caudal vertebral body. The vertebralbodies above and below the disc space by virtue of their engagement andpenetration by the BDFT screws are thus linked and eventually fused. Thegear box casings of the BDFT screws prevent vertebral body subsidence.The inside of the denuded intervertebral space can then be packed withautologous or allograft bone, BMP, DBX or similar osteoinductivematerial. Posteriorly or anteriorly in the lumbar spine, these screwscan be capped with a horizontal mini-plate which will prevent bonygrowth into the thecal sac and nerves. We refer to this as a two-in-onedesign i.e. two BDFT screws combined with one horizontal mini-plate.Anteriorly a total intervertebral spacer containing three BDFT screwscan be inserted. We refer to this as a three-in-one design i.e. threeBDFT screws in one total fusion construct, i.e. an IBFD.

Applicants postulate that BDFT screws provide as strong or strongersegmental fusion as pedicle screws without the complications arisingfrom pedicle screw placement which include screw misplacement withpotential nerve and/or vascular injury, violation of some healthyfacets, possible pedicle destruction and blood loss. By placing screwsacross the intervertebral space from vertebral body to vertebral bodyengaging anterior and middle spinal columns, and not into the vertebralbodies via the transpedicular route, some of the healthy facet jointsare preserved. Because this technique accomplishes both anterior andmiddle column fusion, without rigidly fixing the posterior column, it inessence creates a flexible fusion. This device therefore is a flexiblefusion device because the preserved posterior joints retain theirfunction achieving at least a modicum of mobility and hence a less rigid(i.e. a flexible) fusion.

The very advantage of trans-pedicular screws which facilitate a strongsolid fusion by rigidly engaging all three spinal columns (anterior,middle and posterior), is the same mechanical mechanism whereby completeinflexibility of all columns is incurred thereby leading to increasingrostral and caudal segmental stress which leads to an increased rate ofre-operation.

Transvertebral fusion also leads to far less muscle retraction, bloodloss, and significant reduction in O.R. time. Thus the complication ofpedicular screw pull-out and hence high re-operation rate associatedwith the current embodiment of flexible fusion pedicle screws/rods isobviated. The lumbosacral BDFT screws can be introduced via PLIF, TLIFor ALIF operative techniques. Although one can opt to supplement thesescrews with transpedicular screws there would be no absolute need forsupplemental pedicle screw fixation with these operative techniques.

Bi-directional fixating transvertebral (BDFT) screws can also becombined with novel zero-profile horizontal cervical and lumbarmini-plates. They can also be combined with a total IBFD with insertionspaces for bone material insertion.

For the performance of anterior cervical, and lumbar anterior orposterior fusions one or two centrally placed BDFT screws anterior to aninterverterbal graft or spacer, may be a sufficient barrier by itself toprevent device/graft extrusion. However, to further safeguard againstgraft/spacer extrusion, applicants have devised horizontal linearmini-plates which can be incorporated into two anteriorly placed BDFTscrews. It can also be incorporated into two posteriorly BDFT screwswhich are inserted posteriorly, in addition to a third BDFT screw whichhas been inserted centrally and posteriorly. This achieves a total discintervertebral construct placed posteriorly composed of three BDFTscrews placed in a triangulating matter. The capping horizontalmini-plate would prevent the bony material which is packed into theinterspace from growing into the ventral; aspect of the nerves. Thehorizontal linear mini-plates traverse the diameter of the disc spaceand most of the disc space height. Thus a horizontal mini-plate placedposteriorly immediately beneath the lumbosacral thecal sac and nerveroots which is capped and secured to right and left BDFT screws, wouldprevent intervertebral device/graft extrusion. This mini-plate isessentially a zero- to sub-zero-profile plate in that it is either flushwith or below the rostral and caudal vertebral body surfaces.

Because the BDFT screws engage a small percentage of the rostral andcaudal vertebral body surface area, this plating system could beperformed at multiple levels. This plating system which utilizes BDFTscrews in the anterior cervical spine does not lead to any esophagealcompression/injury, or vascular iliac vein injury in the lumbar spine.For the performance of two or three level intervertebral fusion withhorizontal mini-plates there is virtually no possibility of platebreakage which can occur in long vertical anterior plates which are incurrent usage. Similarly, screw dislodgement, if it occurs would lead tominimal esophageal compression or injury compared to large verticalplate/screw dislodgement. In addition, in the cervical spine BDFT screwplacement closer to the midline would avert any possibility of lateralneural or vertebral artery injury. Likewise multiple placement of IBFDdevices can also be performed without the above mentioned risks andcomplications.

If one were inclined to further enhance posterior columnthoracolumbosacral fixation, applicants introduce a novel calibratedfacet stapling device which staples the inferior articulating facet ofthe superior segment to the superior articulating facet of the caudalvertebral segment unilaterally or bilaterally, further minimizing motionuntil interbody fusion occurs. The degree of flexibility can be furthermodulated by varying the calibration strength and torque of facetstapling. This would be dictated by the need for greater or lesserdegrees of motion preservation. All other know transfacet stabilizersare not calibrated, but are static.

Currently, failed anterior lumbar arthoplasties are salvaged by combinedanterior and posterior fusions. BDFT screws and/or IBFDs could beutilized as a one-step salvage operation for failed /extruded anteriorlyplaced lumbar artificial discs obviating the above salvage procedureswhich have greater morbidity. Likewise, for anterior cervical fusion,applying cervical BDFT screws alone or in combination with cervicalmini-plates or IBFDs addresses the deficiencies and complications ofcurrent cervical plating technology as mentioned above.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates an isometric view of the universal bidirectionalscrew (UBS) alternatively referred to as the bi-directional fixatingtransvertebral screw (BDFT).

FIG. 1B illustrates the lateral view of the UBS (BDFT) with rostral andcaudal screws partially extended.

FIG. 1C illustrates the lateral view of the UBS (BDFT) with the screwswithdrawn.

FIG. 2 illustrates a front view of the UBS (BDFT) without the gear boxand cover.

FIG. 3A and 3B illustrate perspective, and exploded perspective views,respectively, of the UBS (BDFT) without gear box and cover, with thescrews fully extended.

FIG. 4 illustrates a perspective view of the UBS (BDFT) without the gearbox and cover, with screws partially extended.

FIG. 5A illustrates a perspective view of a single insertion screw ofthe BDFT.

FIG. 5B illustrates a perspective cross-sectional view of a BDFTinsertion screw.

FIG. 5C illustrates a perspective view of the spindle.

FIG. 6A illustrates an exploded view of the two-in-one design consistingof two BDFT screws and a horizontal mini-plate.

FIG. 6B illustrates the two-in-one design with the horizontal mini-platesecured and the screws extended.

FIG. 6C illustrates the two-in-one design, and its position with respectto the vertebral body.

FIG. 7A illustrates an exploded view of the three-in-one system (IBFD)which consists of three BDFT screws in an enclosure system.

FIG. 7B illustrates the three-in-one system (IBFD) with screws extended.

FIG. 7C illustrates the IBFD with an accompanying screw driver.

FIGS. 8A and 8B illustrate perspective, and cross-sectional views of theinterarticular joint stapling device with staple, respectively.

FIGS. 9A and 9B illustrate perspective and exploded views of the staple,respectively.

FIG. 10 illustrates a perspective view of the staple gun engaging thefacet joint.

FIG. 11 illustrates the remote action mechanism of the staple gun.

FIG. 12 illustrates the different components of the staple gun. FIG. 12Aillustrates the drive rod. FIG. 12B illustrates the fulcrum cylinderconnector. FIG. 12C illustrates the grip handle. FIG. 12D illustratesthe cylinder. FIG. 12E illustrates the cylinder with the drive rod.

FIG. 13 illustrates the drive and insertion mechanism of the staple.

DETAILED DESCRIPTION OF THE INVENTION 1. The Medical Device

Referring to FIGS. 1A-5C the above described problem can be solved inthe cervical, thoracic and lumbar spine by insertion into the denudedintervertebral disc space a bi-directional fixating transvertebral(BDFT) screw or (UBS) screws 100.

FIGS. 1A through 1C illustrate three-dimensional views of the UBS/BDFTscrew 100. All its inner components are in the gear box casing 101. Theinternal mechanisms are illustrated in FIGS. 2-5C. FIG. 1A illustratesthe isometric view of the UBS 100 showing the outer gear box 101containing the external mechanism, with superior screw 102 and inferiorscrew 103 extended. There are serrations 104 on the superior andinferior surfaces of the box 101 intended to integrate with the surfaceof the superior and inferior vertebral body surfaces. The gear box 101which is made either of PEEK (polyethylene-ketol) or titanium acts as acolumn preventing subsidence of the disc space. Also seen are thesurface of the worm drive screw 105, and the horizontal mini-plate screwinsert 106 for capping the horizontal mini-plate to the gear box's 101surface (FIGS. 1A-C and 6A-C).

FIGS. 1-4 illustrate the inner components of the BDFT/UBS 100 withoutthe enclosing gear box 101. The inner components include a single wormeddrive screw 105, a drive spindle 201, a spur gear 202, superior screw102 and inferior screw 103 with superior and inferior screw spindles205, 206 (FIGS. 1-4). The mechanism of operation is thus: The wormeddrive screw 105 is rotated clockwise. This rotation in turn rotates thespur gear 202. The spur gear 202 interdigitates with the superior screw102 on one side and the inferior screw 103 on the other side. Rotationof the spur gear 202 leads to simultaneous rotation of the superior andinferior screws 102, 103 in equal and opposite directions. The spindlesin the wormed drive screw 105 and the superior and inferior screws 102,103 maintain the axis of screw orientation. The screws 102, 103 are selfdrilling and hence there is no need for bony preparation.

FIGS. 5A and 5B illustrate in perspective and cross-sectional views thedetailed elements of the superior and inferior screws 102, 103. Thesefigures illustrate the external threading 501, the internal threading502, the spindle socket and the spur gear teeth 503 which interdigitatewith the spur gear 202. The screws 102, 103 are self drilling as noted.

FIG. 5C illustrates the details of the spindle including its base 505,its rod 506 and its threaded segment 507.

FIGS. 6A-6C illustrate the two-in-one design concept. This designconcept includes two UBS/BDFT screws 100 a, 100 b which are placed inthe left and right portions of the intervertebral disc space, which arethen capped by a horizontal mini-plate 600. Note how the mini-plate hasfour perforations. There are two perforations 601, 602, one on each sideto allow entry of the wormed screw drive into the gear box. There are anadditional two perforations 603, 604, one on each side, to secure theplate to the two UBS boxes 100 a, 100 b with plate screw caps 605, 606.FIG. 6C demonstrates the position of the two-in-one system with respectto the vertebral body 610. In between the two BDFT/UBS screws 100 a, 100b, bone fusion material is inserted. The horizontal mini-plate 600prevents the bone from growing into the nerves above it. With thissystem it is also possible to place a third screw inferior and in themiddle of the two other UBS screws 100 a, 100 b thereby providingadditional screw intervertebaral fixation.

FIGS. 7A through 7C illustrate the three-in-one design otherwise knownas the IBFD. This device consists of five components. Three UBS/BDFTscrews 100 a, 100 b, 100 c, a superior and an inferior enclosure 701,702. The enclosures 701, 702 are attached to the UBS/BDFT screws 100 a,100 b, 100 c. A screw driver 705 is used to actuate the screws 100 a,100 b, 100 c. There are also slots 703, 704 for bone fusion material.This device is only for anterior insertion into the spine, and it coversthe entire cross-sectional area of the interspace, and is thus a totalIBFD. The enclosures can be made out of PEEK, titanium, cobalt chromiumor any other similar substance. The structure of the device providessignificant three column stability and prevents subsidence of theconstruct.

FIG. 8A and 8B illustrate the individual components of the facet jointstaple gun 800. It consists of a remote action mechanism which includesgrip handles 801, transmission linkages 802, a drive rod 803, a cylinder804. The drive rod 803 has a force end 805 and an action end 806.

FIGS. 9A and 9B illustrate the details of the facet joint stapler. Thestaple 900 has superior and inferior staple segments 901, 902. Thesesegments 901, 902 are joined by a teethed unidirectional lockingmechanism 903 having right triangular teeth 910, and a spring washer904. The inferior surfaces 905, 906 of each staple segment 901, 902 areserrated to facilitate bony integration, and each segment has two bonepiercing elements 907 with a base 908. FIG. 10 illustrates the staple900 in the staple gun 800, in the opened position engaging the facetjoints, prior to penetration and stapling.

FIGS. 11-13 illustrate the different components of the staple gun 800and staple 900 in a detailed manner. The mechanism of action of thestaple gun 800 includes engaging the staple 900 in the action end 806 ofthe drive rod 803 and resting in the staple guide chamfers 1201 (FIGS.12A-13). When the staple 900 is thus engaged in the staple gun 800, thegrip handles 801 are squeezed together, bringing the linkages 802together (FIGS. 11-12C). This action is transmitted to the force end 805of the driving rod 803 which moves upwards. This leads to upwardmovement of the action end 806 of the drive rod 803 in which the staple900 is nestled, leading to the opposition of the superior and inferiorsegments 901, 902 of the staple, 900 and the penetration of the pins 907into the bone. The distance of bone penetration is modulated by thepressure put on the hand grips 801. Hence graded facet joint oppositionleading to different degrees of opposition and hence rigidity can beaccomplished. The greater the force the greater the opposition. Thusthis is a modulated not a static stapling mechanism.

2. The Surgical Method

The surgical steps necessary to practice the present invention will nowbe described.

The posterior lumbar spine implantation of the BDFT (UBS) screws 100,horizontal mini-plate 600 and IBFD 100 a, 100 b, 100 c can be implantedvia previously described posterior lumbar interbody fusion (PLIF) orposterior transforaminal lumbar interbody fusion (TLIF) procedures. Theprocedure can be performed open, microscopic, closed, tubular orendoscopic. Fluoroscopic guidance can be used with any of theseprocedures.

After the adequate induction of anesthesia, the patient is placed in theprone position.

A midline incision is made for a PLIF, and one or two parallelparamedian incisions or a midline incision is made for a TLIF. For thePLIF a unilateral or bilateral facet sparing hemi-laminotomy is createdto introduce the BDFT (UBS) screws 100, into the disc space after it isadequately prepared. For the TLIF procedure, after a unilateraldissection and drilling of the inferior articulating surface and themedial superior articulating facet, the far lateral disc space isentered and a circumferential discectomy is performed. The disc space isprepared and the endplates exposed.

There are then multiple embodiments to choose from for an intervertebralbody fusion. With the first and simplest choice, under direct orendoscopic guidance one. Two or three BDFT screws 100 can be placed. Iftwo screws 100 are placed. One is placed on the right, and one on theleft. If three are placed, the additional one can be placed moreanterior and midline, such that the three screws 100 a, 100 b, 100 cform a triangulation encompassing the anterior and middle columns of thevertebral bodies.(Figures 6B and 6C). Once the screws 100 are placedinto the desirable intervertebral body positions, the worm drive screws105 are turned clockwise which leads to the penetration and engagementof the superior and inferior bi-directional screws 102, 103 into thevertebral bodies above and below. BDFT screws can also be placed inangled positions if desirable (not illustrated). Bone material oralternative intervertebral fusion material can then be packed into thedisc space around the BDFTs 100. The casing gear box 101 of the screwsprevents subsidence of the vertebral bodies (FIGS. 1A-C). An additionaloption in the posterior lumbar spine is to place a horizontal mini-plate600 underneath the thecal sac to prevent bone migration into the nerves.This plate 600 (FIGS. 6A-C) can be slid underneath the thecal sac, andsecured to the right and left BDFT (UBS) screws 100. Once set, the plate600 can be locked down with plate screw caps 606 thereby preventingmovement (FIGS. 6A-C).

If further posterior column stability or rigidity is required,unilateral or bilateral, single level or multiple level facet screwstapling 900 can be performed under open, microscopic flouroscopic orendoscopic vision. Radiographic confirmation of staple position isobtained. Calibrated stapling leads to opposition of the facet joints1000 with incremental degrees of joint opposition. This can lead tovariable degrees of posterior column rigidity and/or flexibility (FIGS.8-13).

The anterior cervical, thoracic and lumbar spine implantation of one,two or three UBS (BDFT) screws 100 can be performed in a similar mannerto posterior application. Likewise a horizontal mini-plate 600 can beused to cap two BDFT screws 100. Anterior placement of the three-in-onedevice (IBFD) 100 a, 100 b, 100 c into the L4/5 and L5/S1 interspacescan be performed on the supine anesthetized patient via previouslydescribed open micropscopic or endoscopic techniques. Once the discspace is exposed and discectomy and space preparation is performed,placement of one, two or three BDFT screws 100 with or without amini-plate 600, or placement of the IBFD 100 a, 100 b, 100 c isidentical to that performed for the posterior approach.

The posterior placement of the BDFT screws 100 alone or combined withhorizontal mini-plates (two-in-one) 600 or with IBFD 100 a, 100 b, 100 cinto the thoracic spine can be performed via previously describedtranspedicular approaches; open or endoscopic. The anterior placement ofthe IBFD (three-in-one) into the thoracic spine can be accomplished viaa trans-thoracic approach. Once disc space exposure is obtained viaeither approach, all of the above mentioned embodiments can be inserted.Engagement of the devices is identical to what was mentioned above.

For anterior placement of the cervical embodiments of the BDFT screw(s)100 with or without the horizontal cervical mini-plate 600, and the IBFD100 a, 100 b, 100 c embodiment, the anterior spine is exposed in theanesthetized patient as previously described for anterior cervicaldiscectomies. Once the disc space is identified, discectomy is performedand the disc space prepared. Implantation and engagement of all devicesis identical to that described for the anterior lumbar and thoracicspines.

The present invention may provide an effective and safe technique thatovercomes the problems associated with current tanspedicular-basedthoracic and lumbar fusion technology, and with current verticalcervical plating technology, and for many degenerative stable andunstable spine diseases, and could replace many pedicle screw-based andanterior vertical-plate based instrumentation in many but not alldegenerative spinal conditions. Calibrated facet joint screw staples 900can facilitate flexible fusions and could replace current statictrans-facet screws.

To our knowledge there has not been any other previously describedbi-directional screw 100 for use in the spine, other joints, or for anycommercial or carpentry application. The bi-directional screw 100described herein may indeed have applications in general commercial,industrial and carpentry industries. To our knowledge the description ofzero to subzero profile anterior or posterior horizontal spinal plateswhich traverse the diameter of the disc space has not been previouslydescribed. To our knowledge an intervertebral three-in-one construct 100a, 100 b, 100 c has not been previously reported. To our knowledgecalibrated facet joint staples 900 have not been previously described.

1-20. (canceled)
 21. A bidirectional fixating intervertebral implantsystem, the system comprising: at least one implant body made ofpolyethylene-ketol (PEEK) configured to act to reduce subsidence of adisc space between first and second vertebral bodies when implanted intothe disc space, the implant body having a first vertebral body-facingsurface and an opposing second vertebral body-facing surface configuredfor engaging the first and second vertebral bodies, having aplate-facing surface, and having side surfaces extending between thefirst and second vertebral body-facing surfaces; a plate having a topsurface and an opposing body-facing surface, wherein the plate isconfigured to engage with the implant body with the body-facing surfaceof the plate abutting against the plate-facing surface of the implantbody, wherein the plate comprise a plurality of plate holes aligned witha plurality of body holes of the implant body, wherein the plate has adepth between its top surface and its body-facing surface that varies atdifferent portions of the plate such that at least a portion of thebody-facing surface of the plate is shaped to wrap around at least aportion of the implant body, wherein the implant body and the plate aresized to fit within the disc space when the implant body and the plateare combined and implanted in the disc space; a superior bone-piercingscrew extendable from the at least one implant body in a first directionso as to pierce and engage with the first vertebral body when implantedin the disc space; and an inferior bone-piercing screw extendable fromthe at least one implant body in a second direction different than thefirst direction so as to pierce and engage with the second vertebralbody when implanted in the disc space.
 22. The system of claim 21,wherein the plate is a zero to sub-zero-profile plate configured to beeither flush with or below surfaces of the first and second vertebralbodies when implanted.
 23. The system of claim 21, wherein the bodythickness is greater than the plate thickness.
 24. The system of claim21, wherein at least one of the plate holes extends through the plateorthogonally with respect to the top surface.
 25. The system of claim21, wherein the plate holes and the body holes are substantiallycylindrical.
 26. A method of operating the system of claim 21, themethod comprising: positioning the implant body and the plate in thedisc space such that the plate is either flush with ore below surfacesof the first and second vertebral bodies; extending the superiorbone-piercing screw into the first vertebral body and extending theinferior bone-piercing screw into the second vertebral body so as tosecure the system in the disc space.
 27. A bidirectional fixatingintervertebral implant system, the system comprising: at least oneimplant body made of polyethylene-ketol (PEEK) configured to act toreduce subsidence of a disc space between first and second vertebralbodies when implanted into the disc space, the implant body having afirst vertebral body-facing surface and an opposing second vertebralbody-facing surface configured for engaging the first and secondvertebral bodies, having a plate-facing surface, and having sidesurfaces extending between the first and second vertebral body-facingsurfaces; a plate having a top surface and a body-facing surface,wherein the plate is configured to engage with the implant body with thebody-facing surface of the plate abutting against the plate-facingsurface of the implant body, wherein the plate comprise four plate holeswith at least two of the four plate holes aligned with at least two bodyholes of the implant body, wherein the body-facing surface of the platehas a first portion abutting the implant body and a second portionabutting the implant body, wherein the first portion of the body-facingsurface of the plate is positioned opposite the top surface of the plateand the second portion of the body-facing surface of the plate is angledwith respect to the first portion of the body-facing surface of theplate so as to abut a different portion of the implant body, whereinboth the implant body and the plate are sized to fit within the discspace when the implant body and the plate are combined and implanted inthe disc space; a superior bone-piercing screw extendable from theimplant body in a first direction so as to pierce and engage with thefirst vertebral body when implanted in the disc space; and an inferiorbone-piercing screw extendable from the implant body in a seconddirection different than the first direction so as to pierce and engagewith the second vertebral body when implanted in the disc space.
 28. Thesystem of claim 27, wherein the plate is a zero to sub-zero-profileplate configured to be either flush with or below surfaces of the firstand second vertebral bodies when implanted.
 29. The system of claim 27,wherein at least two of the four plate holes are screw holes.
 30. Thesystem of claim 27, wherein at least one of the plate holes extendsthrough the plate orthogonally with respect to the top surface.
 31. Thesystem of claim 27, wherein the plate holes and the body holes aresubstantially cylindrical.
 32. A method of operating the system of claim27, the method comprising: positioning the implant body and the plate inthe disc space such that the plate is either flush with ore belowsurfaces of the first and second vertebral bodies; and extending thesuperior bone-piercing screw into the first vertebral body and extendingthe inferior bone-piercing screw into the second vertebral body so as tosecure the system in the disc space.
 33. The system of claim 27, whereinthe first portion of the body-facing surface is substantiallyperpendicular to the second portion of the body-facing surface of theplate.
 34. A bidirectional fixating intervertebral implant system, thesystem comprising: at least one implant body made of polyethylene-ketol(PEEK) configured to act to reduce subsidence of a disc space betweenfirst and second vertebral bodies when implanted into the disc space,the implant body having a first vertebral body-facing surface and anopposing second vertebral body-facing surface configured for engagingthe first and second vertebral bodies, having a plate-facing surface,and having side surfaces extending between the first and secondvertebral body-facing surfaces; a plate having a top surface and abody-facing surface, wherein the plate is configured to engage with theimplant body with the body-facing surface of the plate abutting againstthe plate-facing surface of the implant body, wherein the plate comprisea plurality of plate holes aligned with a plurality of body holes of theimplant body, wherein the body-facing surface of the plate has a firstportion abutting the implant body and a second portion abutting theimplant body, wherein the first portion of the body-facing surface ofthe plate is positioned opposite the top surface of the plate and thesecond portion of the body-facing surface of the plate is angled withrespect to the first portion of the body-facing surface of the plate soas to abut a different portion of the implant body, wherein both theimplant body and the plate are sized to fit within the disc space whenthe implant body and the plate are combined and implanted in the discspace; and a plurality of bone-piercing screws extendable from thesystem bidirectionally such that a first of the bone-piercing screwsextends in a first direction so as to pierce and engage with the firstvertebral body when implanted in the disc space and a second of thebone-piercing screws extends in a second direction different than thefirst direction so as to pierce and engage with the second vertebralbody when implanted in the disc space.
 35. The system of claim 34,wherein the plate is a zero to sub-zero-profile plate configured to beeither flush with or below surfaces of the first and second vertebralbodies when implanted.
 36. The system of claim 34, wherein at least oneof the plate holes extends through the plate orthogonally with respectto the top surface.
 37. The system of claim 34, wherein the firstportion of the body-facing surface is substantially perpendicular to thesecond portion of the body-facing surface of the plate.
 38. The systemof claim 34, wherein the plate comprises at least four plate holes. 39.The system of claim 34, wherein the implant body has a body thicknessbetween its first and second vertebral body-facing surfaces and theplate has a plate thickness across the top surface of the plate that issimilar to the body thickness of the implant body.